Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction

NCT ID: NCT06772337

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-31

Brief Summary

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This study adopts a multicenter, open-label, randomized controlled clinical study, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 hospitals as cooperative units.

Detailed Description

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It uniformly deploys an integrated cardiac rehabilitation management platform from the hospital to outside the hospital. Based on this platform, precise cardiac rehabilitation for myocardial infarction patients based on continuous dynamic physiological data is carried out. A total of 160 myocardial infarction patients after PCI who will undergo digital therapy cardiac rehabilitation are randomly divided into a digital cardiac rehabilitation group (experimental group) and a conventional treatment group (control group) at a ratio of 1:1 using a computer random sequence method, with 80 patients included in each group.

Conditions

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Acute Myocardial Infarction Cardiac Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digitalized Cardiac Rehabilitation Group (Experimental Group)

Intervention group patients received in-hospital cardiac rehabilitation during their hospital stay and a digital cardiac rehabilitation program after discharge.

Group Type EXPERIMENTAL

digital cardiac rehabilitation

Intervention Type BEHAVIORAL

Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.

Regular Treatment Group (Control Group)

The patients in the control group received in-hospital cardiac rehabilitation during their hospitalization, and after discharge, they conducted cardiac rehabilitation training at home by themselves and returned to the hospital for regular follow-up.

Group Type EXPERIMENTAL

Regular Treatment

Intervention Type BEHAVIORAL

Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.

Interventions

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digital cardiac rehabilitation

Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.

Intervention Type BEHAVIORAL

Regular Treatment

Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The patient meets the diagnostic criteria for AMI in the "Diagnosis and Treatment Guidelines for Acute ST-Segment Elevation Myocardial Infarction (2019)" and undergoes PCI for the first time;
* The age is between 18 and 75 years old;
* The left ventricular ejection fraction (LVEF) is 35% - 50%;
* The patient has normal cognition and can cooperate with the test;
* The patient signs the informed consent and the agreement to participate in this study.

Exclusion Criteria

* Symptom-limited cardiopulmonary exercise test (treadmill) contraindications:

1. Uncontrolled acute coronary syndrome;
2. Acute heart failure;
3. Symptomatic severe aortic stenosis, severe aortic coarctation or descending aortic aneurysm;
4. Acute aortic dissection;
5. Acute myocarditis, pericarditis or endocarditis;
6. Symptomatic or hemodynamically unstable severe arrhythmia;
7. Severe bradyarrhythmia;
8. Acute pulmonary embolism and pulmonary infarction;
9. Acute respiratory failure;
10. Uncontrolled asthma;
11. Peripheral oxygen saturation \< 88% at rest or heart rate \> 120 beats/min;

s. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg; t. Recent stroke or transient ischemic attack; u. Intermuscular venous thrombosis of the lower extremities; v. Orthopedic injury that hinders walking; w. Mental abnormality; x. Those who cannot cooperate;
* Patients who have not completed revascularization treatment or have planned revascularization within one year;
* Pregnant or lactating patients, or those who plan to become pregnant within one year;
* Patients who have received mechanical circulatory support treatment (such as intra-aortic balloon counterpulsation, Impella, ECMO, etc.) or tracheal intubation;
* Patients with a history of non-ischemic cardiomyopathy such as viral myocarditis or dilated cardiomyopathy, hypertrophic cardiomyopathy, peripartum cardiomyopathy, etc.;
* Patients with moderate or severe valvular heart disease or a history of valve replacement;
* Severe liver function abnormality (ALT ≥ 3 times the upper limit of the normal range) or renal function abnormality (eGFR \< 60 mL/min/1.73 m2);
* Patients with diseases such as malignant tumors and an expected lifespan of less than one year;
* Those who cannot use a smartphone for various reasons and are inconvenient to communicate with the management team;
* Those who are participating in other clinical trials;
* The researcher believes that there are any other clinical conditions that are not suitable for inclusion in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chen Leilei

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangqing Kong

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Xiangqing Kong

Role: CONTACT

13951610265

Leilei Chen

Role: CONTACT

18651856055

Other Identifiers

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DTCR

Identifier Type: -

Identifier Source: org_study_id

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